Pregnancy Outcomes Following Myomectomy

Recruiting

• Conditions: Pregnancy Complications; Uterine Fibroid; Reproductive Issues; Reproductive Sterility
• Interventions: Procedure: Myomectomy

• Registration Number: NCT06474065
• Lead Sponsor: Centro di Ricerca Clinica Salentino

Brief Summary

The most prevalent genital pathology, uterine fibroids have a detrimental impact on the health of women. Fibroid symptoms are typically more impactful on females and frequently require uterine excision. Although contentious in terms of how it affects pregnancy outcomes, hysteroscopic, laparoscopic, or laparotomic myomectomy has always been a necessary and suitable procedure for the patient's health. Numerous studies have been conducted on the topic, but no clear findings have been reached.

The goal of this observational study is to investigate the pregnancy outcomes after hysteroscopic, laparoscopic, laparotomic myomectomies in female patients affected by fibroids. The main questions it aims to answer are:

To investigate pregnancy outcomes in relation to surgical approach used for myomectomy.

To investigate whether pregnancy outcome is different in relation to time when myomectomy was performed: on a pregnant uterus or on a non-gravid uterus.

If there is a comparison group: Researchers will compare a group of patients unsubmitted to surgery, to see the difference with the operated patients.

Participants will follow up, to evaluate the possible pregnancy complications, the intraoperative complications and other perinatal and post-operative complications.

Detailed Description

AIMS:

1. To investigate pregnancy outcomes in relation to surgical approach used for myomectomy.

2. To investigate if pregnancy outcome is different in relation to time when myomectomy was performed: on a gravid uterus or on a non-gravid uterus

Patients enrolled are divided in three major groups:

* Group A: myomectomy outside of pregnancy-A1 hysteroscopic; A2 laparoscopic; A3 laparotomy

* Group B: myomectomy during CS: B1 trans-endometrial; B2 serosal

* Group C: control group with repeated CS

INCLUSION CRITERIA:

1. women of reproductive age (up to 45 yrs)-all groups

2. women who had myomectomy (group A and B)/CS (group C) at least two years before the enrolment

3. myomas 30 mm in size and larger (groups A and B)

4. Study groups: myomectomy performed as hysteroscopic/laparoscopic/laparotomic myomectomy or cesarean myomectomy, both using transendometrial or serosal approach: gravida 2 para 2 or gravida 1 para 1 \[groups A1, A2, A3 and groups B1 and B2\]

5. Control group: women who had cesarean section in their second pregnancy-para 2 gravida 2, at least two years after the CS \[group C\]

EXCLUSION CRITERIA:

1. any previous surgery on reproductive organs except myomectomy

2. any additional operation during cesarean myomectomy procedure except cesarean section

3. history of endometriosis or PID

4. coagulation disorders

5. previous treatment for any malignant disease

6. previous GTD

7. premature ovarian failure or any kind of ovarian insufficiency necessitating oocyte donation

8. systemic diseases: IBD, MS, DM

DATA TO COLLECT:

1. age

2. years after myomectomy or CS(for group C)

3. gravidity

4. parity

5. BMI

6. myoma characteristics (size and type)

7. myomectomy procedure

8. gestational week at delivery

9. primary indication for CS

10. fetal position

11. placental pathology

12. preoperative hematologic values

13. postoperative hematologic values

14. duration of the CS

15. myoma recurrence in groups A and B

16. uterine rupture

17. perioperative transfusion

18. febrile morbidity

19. postoperative hospitalization in days

20. PPH

21. cause of PPH

22. uterine atony

23. relaparotomy

24. hysterectomy

25. blood vessels ligation

26. fetal presentation: cephalic/other

27. neonatal body weight

28. Apgar score

OUTCOMES:

1. pregnancy complications

1. placental pathology: placenta previa, placental abruption, PAS

2. PPROM (gestational age)

3. abnormal presentation: cephalic/other

4. uterine rupture: complete/incomplete

5. preterm/term delivery (gestational age at delivery)

2. intraoperative complications

1. intraabdominal adhesions/PAI score

2. surgery complications: Claven Dindo classification

3. other complications:

1. neonatal outcome,

2. duration of maternal hospitalization,

3. primary or secondary PPH

4. primary or secondary PPH

5. relaparotomy

6. peripartum hysterectomy,

7. ligation of major blood vessels (uterine, ovarian, iliac)

The study will be conducted as a multicentric observational study including cesarean section deliveries in each participating center. In each participating center, one person will be in charge for data collection and filling the SPSS database after obtaining the approval of the local Ethic Committee. As the study is observational and all the procedures will be conducted according to the local practice, informed consent from patients is not necessary.

Following data collection and termination of the study, a single researcher will oversee the SPSS data collection for all the participating centers, checking the quality of data and submitting it for statistical analysis.

Study Timeline

• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-24
• Study First Posted: 2024-06-25
• Study Start: 2024-06-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-10-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1. women of reproductive age (up to 45 yrs)-all groups
2. women who had myomectomy (group A and B)/CS (group C) at least two years before the enrolment
3. myomas 30 mm in size and larger (groups A and B)
4. Study groups: myomectomy performed as hysteroscopic/laparoscopic/laparotomic myomectomy or cesarean myomectomy, both using transendometrial or serosal approach: gravida 2 para 2 or gravida 1 para 1 [groups A1, A2, A3 and groups B1 and B2]
5. Control group: women who had cesarean section in their second pregnancy-para 2 gravida 2, at least two years after the CS [group C]

Exclusion Criteria

1. any previous surgery on reproductive organs except myomectomy
2. any additional operation during cesarean myomectomy procedure except cesarean section
3. history of endometriosis or PID
4. coagulation disorders
5. previous treatment for any malignant disease
6. previous GTD
7. premature ovarian failure or any kind of ovarian insufficiency necessitating oocyte donation
8. systemic diseases: IBD, MS, DM

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated patiens' Group as Group 1	Myomectomy	Patients submitted to hysteroscopic, laparoscopic or laparotomic myomectomy

Primary Outcome Measures

Name	Time	Method
Pregnancy complications	1 year	placental pathology, intraoperative complications, other complications

Secondary Outcome Measures

Name	Time	Method
Intraoperative complications	1 year	intraabdominal adhesions/PAI score, surgical complications: Claven Dindo classification

Trial Locations

Locations (1)

Andrea Tinelli; 🇮🇹 Lecce, Le, Italy